Press Releases

VIVUS Reports Second Quarter 2018 Financial Results

Aug 7, 2018

Company to host conference call today at 4:30pm ET

CAMPBELL, Calif., Aug. 07, 2018 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ: VVUS) (the "Company"), a specialty pharmaceutical company committed to the development and commercialization of innovative therapies focusing on treatments for patients with serious unmet medical needs, today reported financial results for the quarter ended June 30, 2018 and provided a business update.

“The successful completion of the PANCREAZE acquisition and the transaction with Athyrium Capital Management to restructure a portion of our debt and access additional capital are transformative events for VIVUS,” said John Amos, Chief Executive Officer at VIVUS. “We are now strongly positioned to build a robust portfolio of cash flow-positive assets that have clinical and commercial value. Additionally, the positive pharmacokinetic data reported for VI-0106 support continued evaluation of this novel formulation of tacrolimus in the treatment of pulmonary arterial hypertension, a serious disease with no curative therapy. We are exploring options for advancing this promising program in a manner consistent with our focus on reducing our debt. I am excited that we are making tangible progress toward our goal of becoming a profit-generating specialty pharmaceutical company.”

Recent Business Highlights

VIVUS closes PANCREAZE® acquisition and debt restructuring

In June 2018, VIVUS announced that it had met the closing conditions, including Hart-Scott-Rodino review, related to the Company’s acquisition of U.S. and Canadian rights to PANCREAZE (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions from Janssen Pharmaceuticals, Inc. for $135 million in cash. Concurrently, VIVUS completed a financing agreement with affiliates of Athyrium Capital Management, L.P., to restructure a portion of the Company’s debt.

VIVUS announces positive preliminary Phase 1 VI-0106 results for PAH

In July 2018, VIVUS announced positive preliminary results from a Phase 1 clinical study evaluating VI-0106, a proprietary soft capsule formulation of tacrolimus for the treatment of pulmonary arterial hypertension (PAH). The key findings from the pharmacokinetic (PK) study involving healthy volunteers showed that prototype formulations had PK profiles consistent with earlier in-vitro evaluations, and an increased Area Under the Curve compared to available immediate release tacrolimus.

VIVUS Appoints Kenneth Suh as President

VIVUS recently announced the appointment of Ken Suh to the position of President. Previously, Mr. Suh was President and CEO of Willow Biopharma Inc., a wholly-owned subsidiary of VIVUS, Inc.

Financial Results

Revenue consisted of the following:

(In thousands)Three Months Ended

June 30,

2018

2017

Qsymia net product revenue

$

11,134

$

8,518

PANCREAZE net product revenue

2,116

-

Supply revenue

1,042

2,119

Royalty revenue

668

590

Total revenue

$

14,960

$

11,227

Qsymia net product revenue increased to $11.1 million in the first quarter of 2018 as compared to $8.5 million in the second quarter of 2017. The increase was primarily driven by the increase in shipments to 94,000 units in the second quarter of 2018 as compared to 83,000 units in the same period in 2017. Approximately 96,000 and 105,000 Qsymia prescriptions were dispensed in the second quarters of 2018 and 2017, respectively.

PANCREAZE net product revenue was $2.1 million in the second quarter and consists of shipments made from the date of our acquisition of PANCREAZE on June 8, 2018 through June 30, 2018. During this period, we shipped 7,000 units of PANCREAZE.

Total cost of goods sold excluding amortization was $3.3 million and $3.4 million in the second quarters of 2018 and 2017, respectively. The decrease was primarily a result of lower shipments of STENDRA/SPEDRA partially offset by higher shipments of Qsymia and the addition of PANCREAZE product revenue during the quarter.

Amortization of intangible assets was $1.3 million and $181,000 in the seconds quarters of 2018 and 2017, respectively. In 2018, the increase was due to the amortization of costs capitalized associated with the acquisition of PANCREAZE.

Research and development expense was $2.0 million and $1.0 million in the second quarters of 2018 and 2017, respectively. Research and development expenses were impacted by increased development efforts of tacrolimus for the treatment of pulmonary arterial hypertension, specifically the Phase 1 pharmacokinetic study and continued formulation efforts

General and administrative expense was $8.2 million and $6.2 million for the second quarters of 2018 and 2017, respectively. The increase in general and administrative was primarily due to one-time expenses of approximately $2.0 million related to advisory services and expenses related to the acquisition of PANCREAZE and the restructuring of our debt, in addition to the additional expense of adding three new members of our senior leadership team.

Selling and marketing expense for the commercialization of Qsymia totaled $3.5 million and $5.4 million in the second quarters of 2018 and 2017, respectively. The decrease was due to the continued cost control initiatives, including the realignment of our sales force, and the refinement of our marketing and promotional programs.

Total interest expense for the second quarter of 2018 was $8.7 million, as compared to $8.5 million in the second quarter of 2017.

Net loss for the second quarter of 2018 was $12.6 million, as compared to $13.4 million in the second quarter of 2017. Cash, cash equivalents and available-for-sale securities were $123.5 million at June 30, 2018.

Non-GAAP EBITDA for the second quarter of 2018 was ($1.0) million, as compared to ($4.0) in the second quarter of 2017. Excluding the one-time expenses discussed above, VIVUS generated EBITDA of approximately $1.0 million during the second quarter of 2018.

Conference Call Details

VIVUS will hold a conference call and an audio webcast to provide a business update and to discuss the 2018 second quarter financial results today, August 7, 2018, beginning at 4:30PM Eastern Time. Investors may listen to this call by dialing toll-free 1-877-359-2916 in the U.S. and 1-224-357-2386 from outside the U.S. The audience passcode is 7977356. A webcast replay will be available for 30 days and may be accessed at http://ir.vivus.com/events-and-presentations.

About Qsymia

Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.

The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.

Qsymia® (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.

Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

About PANCREAZE

PANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE may help your body use fats, proteins, and sugars from food. PANCREAZE contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas. PANCREAZE is safe and effective in children when taken as prescribed by your doctor.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PANCREAZE?

PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery.

The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you.

The most common side effects include pain in your stomach (abdominal pain) and gas.

Other possible side effects: PANCREAZE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

These are not all the side effects of PANCREAZE. Talk to your doctor about any side effect that bothers you or does not go away.

have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy).

have gout, kidney disease, or high blood uric acid (hyperuricemia).

have trouble swallowing capsules.

have any other medical condition.

are pregnant or plan to become pregnant.

are breast-feeding or plan to breast-feed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The Product Information and Medication Guide for PANCREAZE is available at www.pancreaze.com.

About STENDRA/SPEDRA (Avanafil)

STENDRA® (avanafil) is approved in the U.S. by the FDA for the treatment of erectile dysfunction. Metuchen Pharmaceuticals LLC has exclusive marketing rights to STENDRA in the U.S., Canada, South America and India.

STENDRA is available through retail and mail order pharmacies.

SPEDRA™, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. VIVUS is in discussions with other parties for the commercialization rights to its remaining territories.

STENDRA® (avanafil) is prescribed to treat erectile dysfunction (ED).Do not take STENDRA if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure.

Discuss your general health status with your healthcare provider to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help.

STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following; medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®); some types of oral antifungal medicines, such as ketoconazole (Nizoral®), and itraconazole (Sporanox®); or some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin.

In the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including STENDRA) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor right away.

Sudden decrease or loss of hearing has been rarely reported in people taking PDE5 inhibitors, including STENDRA. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you experience sudden decrease or loss of hearing, stop taking STENDRA and contact a doctor right away. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers or other anti-hypertensives, your doctor may start you on a lower dose of STENDRA.

Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure.

STENDRA in combination with other treatments for ED is not recommended.

STENDRA does not protect against sexually transmitted diseases, including HIV.

The most common side effects of STENDRA are headache, flushing, runny nose and congestion.Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.

About VIVUS

VIVUS is a specialty pharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit www.vivus.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to potential change in our business strategy to enhance long-term stockholder value; risks and uncertainties related to our ability to address or potentially reduce our outstanding balance of the convertible notes due in 2020; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to our ability to identify and acquire development and cash flow generating assets; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE; risks and uncertainties related to our commercialization of PANCREAZE as a new product and our recently changed management team initiating the commercialization of PANCREAZE; risks and uncertainties related to our, or our partner's, ability to successfully commercialize Qsymia; risks and uncertainties related to our ability to successfully develop or acquire a proprietary formulation of tacrolimus as a precursor to the clinical development process; risks and uncertainties related to our ability to identify, acquire and develop new product pipeline candidates; risks and uncertainties related to our ability to develop a proprietary formulation and to demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates; risks and uncertainties related to the timing, strategy, tactics and success of the commercialization of STENDRA (avanafil) by our sublicensees; risks and uncertainties related to our ability to successfully complete on acceptable terms, and on a timely basis, avanafil partnering discussions for territories under our license with MTPC in which we do not have a commercial collaboration; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; and risks and uncertainties related to the impact, if any, of changes to our Board of Directors and senior management team. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2017 as filed on March 14, 2018, and as amended by the Form 10-K/A filed on April 26, 2018, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

A reconciliation between net loss on a GAAP basis and non-GAAP EBITDA is as follows:

Three Months Ended

Six Months Ended

June 30,

June 30,

2018

2017

2018

2017

Net loss

$

(12,574

)

$

(13,386

)

$

(23,227

)

$

(14,442

)

Adjustments:

Interest expense and other expense, net

9,218

8,398

17,567

16,700

Depreciation of fixed assets

65

68

131

139

Amortization of intangible assets

1,273

181

1,364

362

Share-based compensation expense

1,049

741

1,974

1,468

Provision for (benefit from) income taxes

4

1

16

(11

)

Non-GAAP EBITDA

$

(965

)

$

(3,997

)

$

(2,175

)

$

4,216

Use of Non-GAAP Financial Measures

We supplement our condensed consolidated financial statements presented on a GAAP basis by providing an additional measure which is considered non-GAAP under applicable SEC rules. We believe that the disclosure of this non-GAAP measure provides investors with additional information that reflects the basis upon which our management assesses and operates our business. This non-GAAP financial measure is not in accordance with GAAP and should not be viewed in isolation or as a substitute for GAAP net loss and is not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

We define non-GAAP EBITDA as net loss before interest and other expense, depreciation of fixed assets, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. Management believes that non-GAAP EBITDA is a meaningful indicator of our performance and provides useful information to investors regarding our results of operations and financial condition.